PLASTIC ATTACHABLE DUAL PORT

Port & Catheter, Implanted, Subcutaneous, Intravascular

DAVOL, INC.

The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Plastic Attachable Dual Port.

Pre-market Notification Details

Device IDK912702
510k NumberK912702
Device Name:PLASTIC ATTACHABLE DUAL PORT
ClassificationPort & Catheter, Implanted, Subcutaneous, Intravascular
Applicant DAVOL, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City,  UT  84116
ContactAnn Martin
CorrespondentAnn Martin
DAVOL, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City,  UT  84116
Product CodeLJT  
CFR Regulation Number880.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-06-19
Decision Date1991-09-18

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